- Presentations
- 3
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Mirdametinib is a kinase Inhibitor. MedsAcross lists 3 presentations of it from 1 manufacturers, with brand names, strengths, packs and regulatory status for each. It is available for export supply from India to licensed hospitals, importers and physicians, with the documents the destination country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Kinase Inhibitor, Mitogen-Activated Protein Kinase Kinase 1 Inhibitors, Mitogen-Activated Protein Kinase Kinase 2 Inhibitors
- ATC classification
- L01EE Cancer medicines (antineoplastics), subgroup L01E, subgroup L01EE · Cancer medicines (antineoplastics), subgroup L01E
- US FDA first approval
- 11 February 2025
- EU status
- Authorised
- Orphan designation
- Yes
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Capsule, Tablet for oral suspension
- Identifiers
- UNII 86K0J5AK6MCAS 391210-10-9DrugBank DB07101Q27088255
All presentations
3 presentations of Mirdametinib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Gomekli 1 mg tablet for oral suspensionOral | SpringWorks Therapeutics | US FDA | Available on request |
| Gomekli 2 mg capsuleOral | SpringWorks Therapeutics | US FDA | Available on request |
| Gomekli 1 mg capsuleOral | SpringWorks Therapeutics | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Questions and answers
Is Mirdametinib available for export from India?
Yes, on request. MedsAcross lists 3 presentations of Mirdametinib and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Mirdametinib have?
The catalogue lists 1 brand names for Mirdametinib, including Gomekli.
Is Mirdametinib approved by the US FDA?
Yes. The US FDA first approved Mirdametinib on 11 February 2025, according to Drugs@FDA.
Is Mirdametinib authorised in the European Union?
Yes. Mirdametinib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Mirdametinib need cold chain shipping?
No listed presentation of Mirdametinib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Mirdametinib in?
Mirdametinib is classified under ATC code L01EE (Cancer medicines (antineoplastics), subgroup L01E, subgroup L01EE).
References
- Ezmekly: European public assessment report (EPAR). European Medicines Agency. Retrieved 16 September 2026
Request Mirdametinib for export supply
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